Approval Order StatementApproval for the thunder high scaffolding over-the-wire (otw) and rapid exchange (rx) saphenous vein graft (svg) stent systems; the addition of a new manufacturing facility, ave ireland limited, galway, ireland; and the addition of a new contract sterilizer, iotron ebis industries uk, ltd. , oxfordshire, united kingdom. The devices, will be marketed under the trade names of the thunder high scaffolding otw and rx svg stent systems, and are indicated for improving vessel luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions (length <= 40 mm) in saphenous vein grafts with reference vessel diameters between 3. 0 mm and 5. 0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present. The rx delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone ptca perfusion catheter.